Download Elastomeric Products

Survey
yes no Was this document useful for you?
   Thank you for your participation!

* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project

Document related concepts

Organ-on-a-chip wikipedia , lookup

Intravenous therapy wikipedia , lookup

Transcript
Elastomeric
Products
Professional Guide
8
1
The Infusor
Promoting
Patient Mobility
™
The Baxter Infusor,
Intermate and
Folfusor devices
utilise Elastomeric
technology to
provide reliable
infusion treatment
while promoting
patient recovery.
They also improve patients quality of life by allowing
ambulatory treatment without the inconvenience of
programming, power sources and erroneous alarms.
The major indications are:
Infusional chemotherapy
Pain management
Antibiotic therapy (Cystic Fibrosis, Osteomyelitis, HIV)
Chelation (thalassemia)
The administration routes that can be used are:
IV
Intra-arterial
Subcutaneous
Epidural
Pain Management
(incl.wound infusion and nerve blocks)
The Infusor or Intermate – with their lightweight
disposable design and silent operation – allow patients
to continue therapy in any setting. The Infusor and
Intermate offers patients a medication delivery system
that is comfortable, portable and adaptable to both their
therapy and lifestyle needs.
2
2
The Infusor and Intermate may be stored at room
temperature or in the refrigerator. Storage conditions are
determined by drug stability.
To store the Infusor or Intermate at ROOM
TEMPERATURE choose a cool, dry place that is:
Clean
Away from direct sunlight
Away from heat sources such as an oven or heater
How should
the devices
be stored?
Important points to note:
Infusor to extremes of temperature
or direct sunlight.
Patients should try not to get their catheter wet in the
shower.
Patients should keep the Infusor and the Intermate
out of the reach of children.
The Infusor and Intermate are single use only.
The Infusor and Intermate
Where the Infusor or the Intermate
damaged
To store the Infusor or Intermate in
THE REFRIGERATOR:
Make sure the Infusor or the Intermate are not
touching each other so air can circulate around them.
Keep the Infusor or the Intermate in a separate
compartment of the refrigerator.
device.
Epidural administration of drugs other than those
indicated for epidural use could result in serious
injury to the patient.
The Infusor LV device is not designed for rapid
infusion of medications.
If using an INTERMATE device, allow the device to
warm up to room temperature before use (approx 4-6
hours)
3
3
Using the
™
Infusor or
™
Intermate
Getting ready to use
the devices
1. The Infusor should be removed from the
refrigerator directly before use unless
otherwise instructed. The Intermate should
be removed from the refrigerator 4-6 hours
before use unless otherwise instructed.
2.
with soap and water
and dry thoroughly
3.
need on the clean surface. Lay out these
instructions where you can follow them,
without having to touch them, as you
connect your Infusor or Intermate.
4. Check the name of the medication on the
label.
5. Check the expiration date on the label.
6. Check that your name is correct on the
label.
7. Wash your hands with hot water and
soap. Dry thoroughly.
4
Connecting the Infusor or Intermate to the catheter
1
2
3
4
4
5
Remove the luer cap
from the end of the
Infusor or intermate
tubing. Check to make
sure that liquid has moved
to the end of the tubing.
5
Replace the Luer Cap.
6
Flush the IV line as
instructed. Make sure
that the catheter is
clamped, then remove
and discard the end cap.
While still holding the IV
line, pick up the Infusor
tubing, remove the Luer
Cap and connect it to
the catheter.
7
le if not
re possib
e
NB - Wh
Infusor
r of the
restricto
to the
e taped
should b
cilitate
fa
skin to
patients
Store the Luer Cap in the
bag the Infusor came in.
Unclamp the catheter
so that the infusion can
commence.
The patient should place
the Infusor or Intermate
in the mesh bag or belt
bag provided, where the
damaged.
Disconnecting the Infusor or Intermate
1
When the Infusor or
Intermate is empty remove
it from the catheter. If
please refer to the section
2
Close the clamp on the
catheter and disconnect
the Luer Connector end
of the Infusor or Intermate
from your catheter by gently
twisting anti-clockwise.
3
Flush the catheter the way
you have been instructed
and attach a new sterile end
cap. Place the Luer Cap you
saved earlier on the end
of the Infusor or Intermate.
Dispose of the empty Infusor
or Intermate the way you
have been directed.
5
What to do if the
medication does
not infuse
1. Remember the Infusor or Intermate
sure you have waited long enough.
make
2. Check that the IV line is unclamped and that there are no
kinks in the line.
3.
clamp the catheter and
disconnect the Infusor or Intermate. Replace the Luer Cap
on the end of the Infusor or Intermate tubing.
4. Make a note of the Infusor or Intermate code number.
1. Immediately clamp the catheter.
What to do if
the Infusor or
Intermate leaks
or bursts
2. Disconnect the Infusor or Intermate and replace the Luer Cap
on the end of the Infusor or Intermate tubing.
3. Attach a new Infusor or Intermate, or cap the catheter.
4.
5. If your hospital or community service has provided you with
6. Make a note of the Infusor or Intermate code number.
Do not use
the device if
The expiration date on the label has passed.
The name on the label is incorrect.
The balloon has burst or is split.
There is any sign of leaking drug.
There is a split or break in the tubing.
The Luer Cap has been removed or is missing.
The Fill Port Protector Cap is missing or has fallen off.
6
Checking the progress of the infusion
The patient
patient may
may receive
receive more
more than
than one
one Infusor
Infusor or
or Intermate
Intermate to
to deliver
deliver all
all their
The
their medication.
Depending
onnot
theto
type
of Infusor
or Intermate
was
medication.
It is very
important
change
to a new
Infusor orthat
Intermate
given,
it will
take isapproximately
30 minutes
to 7 days
forthe
or or
until
the
old one
completely empty.
Depending
on the
typeInfusor
of Infusor
Intermate that
to empty.
Intermate
was given, it will take approximately 30 minutes to 7 days for
the Infusor or Intermate to empty.
Small-Volume Infusor, Large-Volume Infusor,
Small-Volume Intermate, Large-Volume Intermate
You will know when the Intermate or Large-Volume Infusor is empty as the
balloon will be touching all eight empty indicator bumps on two sides ofthe
Infusor or Intermate. The Infusor or Intermate works slowly so the balloon will
appear to be shrinking over several hours or days.
7KHGLDJUDPEHORZVKRZV\RXDSSUR[LPDWHO\KRZWKHEDOORRQGHÁDWHVRYHUWLPH
Full
1/4 Delivered
1/2 Delivered
3/4 Delivered
Empty
Volume Indicator Buttons
The Infusor
Volume Indicator when Infusor is full
7KHEDOORRQZLOOEHGHÁDWHGZKHQHPSW\
7
Protection Cap
Balloon
Indicator Bumps
Luer Connector
Winged Luer Cap
Large Volume Infusor
™
Small Volume Infusor
™
Protection Cap
Balloon
Winged Luer Cap
Luer Connector
4
Parameters
for Use
Temperature
Viscosity
The Infusor device is designed to operate at the
The Infusor device is designed to operate at the nominal
2C1073KJ, 2C1063K, and 2C1009K are at a
temperature of 31.1° C (88°F). All other Infusor codes
There will be an approximate 10% increase in the
used.
The Intermate device is designed to operate at the
The Intermate device is designed to operate at the
Flow rate will decrease approximately 2.3% per 1°
C (1.8° F) decrease in temperature and will increase
approximately 2.3% per 1° C (1.8° F) increase in
temperature.
Head height
Flow rate of the Infusor device is optimised when
the Elastomeric Reservoir and the Distal End Luer
Lock are positioned at the same height. Flow rate will
decrease approximately 0.5% per 2.54 cm (1 inch) if
the Elastomeric Reservoir is positioned below the Distal
End Luer Lock. Flow rate will increase approximately
0.5% per 2.54 cm if the Elastomeric Reservoir is
positioned above the Distal End Luer Lock.
10
when 5% Dextrose (D5W) is used.
Catheter size
When delivering solution through a catheter refer to the
directions for use provided by the catheter manufacturer.
The length, diameter, and location of the catheter can
diameter catheter should be used with the Infusor to
An 18 gauge (4 French) or larger diameter catheter
should be used with the Intermate to achieve nominal
5
Troubleshooting
Problem Description
High Flow
Where was the flow restrictor placed on the patient?
The Infusor operates at the labelled nominal rate when the Infusor
skin in the correct location (See temperature information.)
Infusor
Intermate operates at the labelled nominal rate
Intermate contents must be at room
temperature in order for the Intermate
information.)
What was the viscosity of the solution in the device?
See viscosity information.
Was the flow within tolerance?
The Infusor
Intermate
Was any direct heat source (heating pads, heated water bed, heating blanket) or indirect
heat source (sunlight) placed on or near the flow restrictor of the Infusor or the housing of
the Intermate? Was the patient’s body temperature elevated?
Direct or indirect heating of the Infusor
Intermate
What volume of drug/diluent was used in the device?
Infusor
Was the flow restrictor placed at the same head height as the Infusor?
See the Head Height information.
11
Problem Description
Low Flow & No Flow
Was the flow within tolerance?
The Infusor
Intermate
Was the flow restrictor in contact with any cooling source?
Was the flow restrictor taped to the patient’s skin?
Was the filled Intermate brought to room temperature prior to use?
restrictor will change the viscosity of the drug solution contained inside – thereby changing the
Cooling the Infusor or Intermate
Infusor
The Intermate
What was the viscosity of the solution in the device?
See Viscosity information.
What volume of drug/diluent was used in the device?
Infusor
chart.
Was the flow restrictor placed at the same
head height as the Infusor?
See Head Height information.
Was air removed from the Infusor tube set and flow restrictor prior to use?
Was flow verified by visualising 2-3 drops of fluid flowing from the flow restrictor at the
time of the filling and at the time of use?
Air in the Infusor
12
Problem Description
Priming Difficulty
Were Baxter filling chart instructions followed? Was the Infusor filled slowly?
Was the Infusor filled while holding the device in a vertical position?
our Quality Assurance Laboratories. This technique should be used for optimal priming
Infusor very slowly. Remember to gently and slowly crack
Was force-priming technique utilised?
Was continuous suction applied during force-priming?
Was three-way stopcock open during force priming? Was a 10mL or smaller syringe
used to force prime the device?
results.
Problem description
Leaks
Was the fill port capped after filling? Was the fill port swabbed after filling?
this type of complaint report, suggest that the customer wipe away residual solution with
leakage of this residual solution.
Was the Winged Luer Cap tightened after filling the device?
The Winged Luer Cap is not tightened during the manufacturing process. The Customer
Problem description
Ruptures
Was the Infusor stored in the presence of sunlight or UV light?
Sunlight or UV light may damage the Elastomeric material of the Infusor and Intermate
reservoirs.
13
6
Large Volume Infusor
Specifications
Name
LV10
LV5
LV2
LV1.5
Code
2C1063KP
2C1009KP
2C1008KP
2C1087KP
1 day
2 days
5 days
7 days
240 mL
240 mL
240 mL
252 mL
31.1°
31.1°
33.3°
33.3°
21.8-26.7 hrs
43.6-53.3 hrs
109.1-133.3 hrs
152.7-186.7 hrs
Nominal Infusion duration
Nominal Flow Rate
Nominal Fill Volume
Nominal Temperature
Flow Rate Accuracy
Acceptable Flow Times
Folfusor
Specifications
Name
SV2.5
SV0.5
SV5
Code
2C4711K
2C4700K
2C4705K
2 days
7 days
1 Day
120 mL
84 mL
120 mL
33.3°
33.3°
33.3°
43.4-53.2 hrs
153.4-186.2 hrs
21.49-26.40 hrs
Nominal Infusion duration
Nominal Flow Rate
Nominal Fill Volume
Nominal Temperature
Flow Rate Accuracy
Acceptable Flow Times
Small Volume Infusor
Specifications
Name
Half Day
Single Day
Two Day
Multi Day
Seven Day
Code
2C1073KJP
2C1071KJP
2C1075KJP
2C1080KJP
2C1082KJ
12 hours
1 days
2 days
5 days
7 days
Nominal Fill Volume
60 mL
48 mL
96 mL
60 mL
84 mL
Nominal Temperature
31.1°
33.3°
33.3°
33.3°
33.3°
10.7-13.7 hrs
21.3-27.4 hrs
42.7-54.9 hrs
106.7-137.1 hrs
149.3-192.0 hrs
Nominal Infusion duration
Nominal Flow Rate
Flow Rate Accuracy
Acceptable Flow Times
14
Acceptable Flow Times
at Nominal Conditions
Intermate
Specifications
Name
SV200
SV100
SV50
LV250
LV100
LV50
XLV250
Code
2C1714K
2C1712K
2C1710K
2C1724K
2C1722K
2C1720K
2C1754K
30 mins
60 mins
120 mins
60 mins
2.5 hrs
5 hrs
120 mins
100 mL
100 mL
100 mL
250 mL
250 mL
250 mL
500mL
21.1°
21.1°
21.1°
21.1°
21.1°
21.1°
21.1°
26-35 mins
52-71 mins
104-141 mins
52-71 mins
2.2-2.9 hrs
4.3-5.9 hrs
1.4-2.2 hrs
Nominal Infusion duration
Nominal Flow Rate
Nominal Fill Volume
Nominal Temperature
Flow Rate Accuracy
Acceptable Flow Times
Accessories
Specifications
Name
Belt Bag 18 inch
waist strap
Belt Bag Small
Mesh Bag for
the Infusor
Code
IPB102XLX1
2C1100
BG3386WH
30
6
500
Pack Size
Infusor Applications
LV the Infusor
Large volume the Infusor used for Chemotherapy, Antibiotics and Pain Management
SV the Infusor
Small Volume the Infusor used for Chemotherpay and Pain Management
Folfusors
Small Volume the Infusor for Chemotherapy
The Intermate
Fast flowing devices for Antibiotics and IVig Infusions
15
7
Can concurrent Infusions be run with
the Baxter Infusor?
Why is it important to place the end of the
administration tubing close to the skin?
Yes. Concurrent infusions may be run via a Y-Site or
The end of the administration tubing is where the Infusor
rate of the Infusor may decrease, particularly if the
pressure of the alternate infusion device is high. It is also
Infusor
restrictor is calibrated to work best at a temperature of
31-33°C so placement next to the skin helps to maintain
this constant temperature.
from one line into the other.
Is the Infusor Recyclable?
The Infusor is made from recyclable material, however
disposal of the device should be in accordance with
individual hospital protocol.
Can the Infusor be used by patients
with latex allergies?
Yes, all Baxter Infusor, Folfusor and Intermate devices
are free of natural latex.
16
Can the Infusor be used inside MRI machines or
Hyperbaric chambers?
Yes, the Infusor does not contain any metal so is suitable
to go through an MRI machine. The Infusor may also be
used inside hyperbaric chambers. As long as the patient
is exposed to the same changes in pressure as the
Infusor device there is no hindrance to the infusion.
Frequently Asked Questions
Quick Reference Guide
Can extension sets be used with
the Baxter Infusor?
A small air bubble is noticeable in the filled Infusor
reservoir – is this an issue?
at the distal end of the Infusor administration tubing
should still be taped to the skin if possible. Extension sets
should be primed prior to connection to the patient. As
a general guide, overall infusion time will be marginally
lengthened when using an extension set.
of air bubbles are introduced into the reservoir. These
port of the devices. The total volume of these bubbles
Can Baxter Infusor and Intermate devices
be used during flight?
Yes, Baxter has conducted internal
testing to establish the effects of cabin pressure on
indicate that the reduced pressure environments such as
effect on solution de-gassing. Neither reduced pressure
environment nor changes in gravitational acceleration
technique is used.
Air that is inadvertently introduced during the
compounding process cannot be withdrawn through the
system (ie. syringe, diluent container, or transfer set) prior
17
18
19
For further information and support for your
Baxter Customer Support on:
Australia: 1300 789 646
New Zealand: 0800 229 837
AUSTRALIA
Baxter Healthcare Pty Ltd
ABN 43 000 392 781
1 Baxter Drive, Old Toongabbie
NSW 2146 Australia
Tel: +612 9848 1111
www.baxterhealthcare.com.au
NEW ZEALAND
Baxter Healthcare Ltd
33 Vestey Drive, Mount Wellington
Auckland 1060, New Zealand
Tel: +649 574 2400
www.baxter.co.nz
www.thehomecalling.com.au
www.baxterhealthcare.com.au
Alternatively, please visit our website
© 2012 Baxter Healthcare Pty Ltd.
Infusor, Folfusor and Intermate are trademarks of Baxter International Inc.
www.thehomecalling.com
AUS2012PRO0036
for additional technical and clinical information.
1